Kornimate/medical-research-clean huggingface dataset:
psychiatric disorders and covid-19

Conditions: Psychiatric Disorder; Covid19

Summary: given the possible risks and complications of a comorbidity between psychiatric disorder and coronavirus disease 2019 (covid-19), it seems particularly important to specify the impact of the covid-19 pandemic in patients with psychiatric disorders and suspected of infection, hospitalized in a specific unit, at the psychiatric, somatic and pharmacological level.

covid-19's possible impact on psychiatric disorders has been little studied. however, patients with psychiatric disorders may be at higher risk of covid-19 contamination, may experience delayed treatment when infected, may have a poor prognosis in terms of complications and success of treatment for covid-19 but also for the underlying psychiatric disorder which could be exacerbated, and finally their psychotropic pharmacological treatment could be impacted by the inflammatory state linked to covid-19. the present study is an observatory of patients with psychiatric disorders and suspected to be infected by the covid-19, hospitalized in a specific unit dedicated to the treatment of this comorbidity in the university hospital of nantes (france). the primary objective is to investigate the impact of the covid-19 pandemic on the level of acute traumatic stress response. secondary objectives include: (i) a description of the sample included; (ii) an assessment of the clinical evolution of these patients 4-6 weeks after admission; (iii) to investigate the links between the levels of stress, peritraumatic distress, and traumatic stress (whether it is acute or has evolved into a post-traumatic stress disorder (ptsd)); (iv) to investigate the links between resilience and coping on the one hand, and stress, peritraumatic distress and traumatic stress (acute or ptsd) on the other hand; and (v) to measure the impact of covid infection and of the reduction on the residual plasma concentrations of psychotropic medications (especially antipsychotics and lithium).

Eligibility criteria:
inclusion criteria: * all patients hospitalized in the protection covid-19 psy unit from the nantes university hospital may be included, without maximum age limit. minors, pregnant or nursing women, and patients under guardianship and tutorship may be included, taking into account the study population and the low risks and constraints of the study (observatory) exclusion criteria: * minors under 15 years; * safeguard of justice; * inability to consent (non-opposition); * not mastering the reading and writing of the french language well enough.

Keywords: psychiatry covid-19 psychological impact acute stress, pharmacological impact pharmacological impact
bifidobacterium lactis hn019 supplementation for prevention of influenza infection in healthy adults

Conditions: Influenza

Summary: to determine if prophylactic supplementation with b. lactis hn019 reduces the risk of developing physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period.


Eligibility criteria:
inclusion criteria: * healthy free-living men and women aged 18 to 60 years * body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight) * subject owns a refrigerator and is willing to keep study product refrigerated at all times * ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study, including possible risks and side effects * consent to the study and willing to comply with study product and methods exclusion criteria: * influenza vaccination in last 6 months, or any other vaccination in previous 15 days * clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial * chronic nasal, laryngeal, pleural, or respiratory condition that could mimic or obscure symptoms of influenza (e.g. chronic allergic rhinitis, asthma, copd, as determined by medical history and baseline physical examination) * chronic use of medication(s) that could suppress or prevent flu-like symptoms (eg, antihistamines, cough medicines; echinacea, high-dose vitamin c) * use of medication(s) within the previous 3 months that affect immune response (eg, antibiotics) * contraindication to dairy products or any other substance in the study product (eg, lactose intolerance) * history of alcohol, drug, or medication abuse * pregnant or lactating female, or pregnancy planned during study period * daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 3 months of screening * participation in another study with any investigational product within 3 months of screening * investigator believes that the participant may be uncooperative and/or noncompliant, and should therefore not participate in the study

Keywords: influenza prevention probiotic
ser-262 versus placebo in adults with primary clostridium difficile infection to prevent recurrence

Conditions: Clostridium Difficile Infection

Summary: the study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. this study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) clostridium difficile infection (cdi).

ser-262-001 is a phase 1b, randomized, double blind, placebo-controlled, ascending single dose clinical study with 2 treatment arms (ser-262 or placebo) in up to 8 dose cohorts. patients who have been diagnosed with their first (primary) episode of cdi, defined as diarrhea (≥ 3 unformed stools per day for 2 consecutive days), a positive c. difficile stool test and who have responded to standard-of-care antibiotic will receive investigational drug or placebo on day 1.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, indicating that the subject understands the purpose of and procedures required for the study. 2. male or female subjects ≥ 18 years. 3. a primary (first) episode of cdi with documentation of the episode including cdi date, test results, antibiotic treatment (including start and stop dates), and response to treatment exclusion criteria: 1. females who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study. 2. known or suspected toxic megacolon and/or known small bowel ileus. 3. active irritable bowel syndrome with diarrhea within the previous 12 months. 4. major gastrointestinal surgery (eg, significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy) or any history of total colectomy or bariatric surgery. 5. history of inflammatory bowel disease (ulcerative colitis, crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 12 months. 6. estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73m2 7. admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). patients discharged from an intensive care unit before day 1 may be enrolled. 8. concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor). 9. absolute neutrophil count \< 500 cells/mm3

Keywords: clostridium difficile c diff cdi
topotecan and carboplatin in the first-line treatment of patients with extensive stage small cell lung cancer

Conditions: Carcinoma, Small Cell

Summary: this proposed phase ii trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage sclc. topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. this trial will be one of the first clinical trials to evaluate a combination of weekly topotecan and carboplatin in the first-line treatment of extensive-stage sclc.

eligible patients will receive treatment with carboplatin and topotecan. topotecan 4mg/m2 iv on days 1, 8. carboplatin auc=5 iv day 1 only . - cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). restaging studies will be performed every 2 cycles (or 6 weeks.)

Eligibility criteria:
inclusion criteria: * patients must have confirmed small cell lung cancer with extensive stage disease. this includes patients with stage iiib and iv disease. * patients with small cell histology are eligible. large neuroendocrine or mixed small cell and non-small cell histology are not eligible. * patients must have measurable or evaluable disease. * ecog performance status 0 or 1. * patients must have adequate bone marrow, liver and kidney function * the patients may have had no previous chemotherapy. * patients must be able to understand the nature of the study and give written informed consent. exclusion criteria: * patients with limited stage disease. this includes ia, ib, iia, iib, and iiia. * age \< 18 years old. * history of a prior malignancy within three years with the exception of skin cancer (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma or stage a/b prostate cancer. * female patients who are pregnant or are breast feeding * history of acute myocardial infarction or stroke within 6 months. * uncontrolled hypertension, unstable angina, new york heart association grade ii or greater chf, serious cardiac arrhythmia requiring medication, or grade ii or greater peripheral vascular disease. * patients who have received other investigational drugs within 28 days. * patients with cns involvement (brain or meningeal). the single exception to this is the patient previously treated for brain metastases with radiation therapy, or surgical excision who has no evidence of active residual metastases on brain mri at the time of study entry. * patients with large neuroendocrine tumor or mixed small cell and non-small cell histology

Keywords: lung cancer carcinoma, small cell
systematically assessing effects of colored light on humans with a multi-modal approach (substudy 3 of 7)

Conditions: Exposure to Man-made Visible Light

Summary: note: this is the third of in total 7 sub-studies related to the ethics committee of the canton of bern ref. no. kek-be 2016-00674. this sub-study includes 50 participants and 6 arms, in total 350 participants will be assessed in all 7 sub-studies. general study information: this is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. the participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. the risk for the participants is negligible and comparable to the risk during daily life.


Eligibility criteria:
inclusion criteria: * normal color vision * right handed * written informed consent exclusion criteria: * smoking * any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months * acute severe traumas * chronic diseases with the necessity for medication * use of recreational drugs * regular intake of medication that would affect the outcome measures * regular excessive alcohol use (\> 18 standard units / week) * transmeridian travel in the last month (crossed \> 1 time zone border) * night shift word during the last month

Keywords: cerebral oxygen metabolism functional near-infrared spectroscopy partial pressure of carbon dioxide heart rate variability blood pressure affect mood respiration systematic randomized cross-over study systemic physiology electro-dermal activity pulse-respiratory quotient
the treatment efficacy of prolotherapy in bladder voiding dysfunction

Conditions: Overactive Bladder; Underactive Bladder

Summary: voiding dysfunction including overactive bladder, underactive bladder, and neuropathic bladder. voiding dysfunction has a great impact on life quality, especially in the elderly society. the current medication for overactive bladder has limited efficacy and the patient easily to dropout the medication because of its side-effects. the underactive bladder is a new entity of voiding dysfunction, its optimal is still unknown. sacral neuromodulation(snm) and posterior tibial nerve stimulation(ptns) have been applied for both overactive bladder and underactive bladder treatment and the results is promising, but the equipment of snm or ptns is not available in most places. prolotherapy using glucose local injection causing inflammatory reaction to stimulate cytokine and growth factors release. investigators combined the concepts of posterior tibial nerve stimulation and prolotherapy to treat voiding dysfunction. investigators anticipate it maybe a new promising treatment for voiding dysfunction.

inclusion criteria:1. adults over 20 years-old. 2. the patient who meets the diagnostic criteria of overactive bladder or underactive bladder. 3. the patient who capable to complete 3-days voiding diary and the questionnaire. exclusion criteria: 1. the patient has severe stress urinary incontinence, severe pelvic organ prolapse, acute urinary tract infection, urolithiasis, or urinary tract malignancy. 2. the patient who has active skin disease on legs or not suitable for leg local injection. 3. pregnant women. method: 40 overactive bladder patients and 40 underactive bladder patients. the patients will receive 5% glucose 10ml local injection peripheral to posterior tibial nerve near ankle under ultrasound guidance once a week for 4 weeks, then the patients will be followed up once-a-month for 3 months. overactive bladder symptom score(oabss), core lower urinary tract symptom score(clss) questionnaire, 3-days voiding diary, and urine nerve growth factor are used for assessment.

Eligibility criteria:
inclusion criteria: 1. adults over 20 years-old. 2. the patient who meets the diagnostic criteria of overactive bladder or underactive bladder. 3. the patient who capable to complete 3-days voiding diary and the questionnaire. exclusion criteria: 1. severe stress urinary incontinence or severe pelvic organ prolapse. 2. acute urinary tract infection. 3. active hematuria, urolithiasis, or neoplasm of urinary tract. 4. acute skin lesion over the ankle injection site or the patient who could not tolerate ankle injection. 5. pregnant women.

Keywords: neural prolotherapy detrusor underactivity overactive bladder
effects of respiratory physiotherapy on pleural effusion

Conditions: Pleural Effusion

Summary: pleural effusion and the complexity of diagnosis and treatment make planning and delivering care challenging. respiratory physiotherapy is recommended, and should be applied during the first weeks of treatment.the aim of the present study is to demonstrate the effectiveness of a respiratory physiotherapy protocol in patients with pleural effusion who attended a university hospital.

approximately 1.5 million patients are diagnosed with pleural effusion each year in the united states . pleural effusion (pe) is an accumulation of fluid in the pleural space that is classified as transudate or exudate according to its composition and underlying pathophysiology. the goal in the management of pleural effusion is to provide symptomatic relief by removing fluid from the pleural space and to allow the treatment of the underlying disease. while some authors (ref) propose respiratory physiotherapy, in the majority of the cases only the medical treatment combined with the pleural fluid removal by thoracentesis are the most common practice. the objective of this study is verify the effectiveness of respiratory physiotherapy in pleural effusion

Eligibility criteria:
inclusion criteria: * diagnosis of pleural effusion based on the presence of a consistent radiological finding on simple posteroanterior and lateral chest x-rays, and decubitus lateral in cases of small pe. exclusion criteria: * non diagnosis of pleural effusion

Keywords: pleural effusion respiratory physiotherapy length of stay
comparison of the efficacy and tolerability of solaraze for 3 versus 6 months in patients with mild to moderate actinic keratosis located on the face and head

Conditions: Photosensitivity Disorders

Summary: topical treatment of mild to moderate actinic keratosis located on the face and head with solaraze® is known to be a safe and efficient treatment option. however, it is unclear if an expansion of the treatment period to 6 months will increase the rate of complete responses. therefore the investigators will evaluate the efficacy and safety of the treatment of actinic keratosis with solaraze® applied twice daily to the face and head over 3 or 6 months of treatment.


Eligibility criteria:
inclusion criteria: * visible and histologically proven actinic keratosis * prepared and able to give written informed consent * ≥ 18 -80 years of age * prepared and comply with all study requirements, including the following: application of gel on the treatment area twice a day, 5 / 7 clinic visits during the prestudy, treatment, posttreatment, and follow-up period * pre- and posttreatment biopsy for histological confirmation (of clearance) of actinic keratosis diagnosis exclusion criteria: * data of clinically significant, unstable, cardiovascular or haematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases * known allergies to any excipient in the study drug * any dermatological disease and/or condition in the treatment or surrounding area (3 cm distances from treatment area) that may be exacerbated by treatment with diclofenac or cause difficulty with examination * active chemical dependency or alcoholism, as assessed by the investigator * currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 30 days * received topical treatment at the treatment area with imiquimod or 5-fu within a time period of 1 month * invasive tumours within the treatment area, e.g. merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed

Keywords: actinic keratosis diclofenac sodium
neuroendocrine modulation of metabolic effects in overweight adolescents

Conditions: Obesity

Summary: this study will examine hormonal differences in ghrelin and growth hormone in obese and normal weight adolescents and their relationship to body composition and insulin resistance. the study will also investigate the effect of the macronutrient composition of a meal on postprandial ghrelin levels and whether ghrelin responses will predict the degree of hunger and caloric intake at a subsequent meal.

obesity is an epidemic that is striking people at younger ages than ever before. obesity is associated with changes in the secretory patterns of several hormones including ghrelin, growth hormone (gh), and insulin, which have not been examined in the adolescent age group. ghrelin, a primarily gastric hormone, increases appetite and is a gh secretagogue. this study will compare the alteration in secretion of ghrelin and gh in overweight and normal weight adolescent girls through frequent blood sampling and gh stimulation testing with growth hormone releasing hormone and arginine. the relationship between these hormones and insulin resistance, measured by 1h-nuclear magnetic resonance spectroscopy, and body composition, measured by dual energy x-ray absorptiometry and magnetic resonance imaging, will be investigated. this study will also determine the postprandial ghrelin response to test meals that vary by the type of predominant macronutrient, which may predict the degree of hunger and amount of intake at a subsequent meal. understanding obesity-related changes in ghrelin and gh and their relationship to body composition, insulin resistance, and appetite will help in the development of strategies to reduce complications of obesity.

Eligibility criteria:
inclusion criteria: 1. girls 12-18 years of age 2. obese subjects: bmi higher than the 95th percentile for age and sex 3. normal-weight controls: bmi from the 15th to the 85th percentiles for age and sex exclusion criteria: 1. history of disorders other than obesity that may affect growth hormone, ghrelin, cortisol, or insulin secretion such as eating disorder, diabetes mellitus, hypertension, thyroid disease, cushing's syndrome, liver disease, renal failure, or an excess or deficiency of gh or cortisol 2. medications that could affect glucose and lipid levels or the secretion of growth hormone, ghrelin, insulin, or cortisol such as rhgh, glucocorticoids, and birth control pills 3. pregnancy 4. smoking or substance abuse 5. active dieting 6. surgical procedures for obesity 7. dietary restrictions such as bread, dairy, peanut, aspartame, or meat products used in the study 8. metal implants, including intracranial surgical clips or pacemakers

Keywords: obesity, adolescent, ghrelin, growth hormone, cortisol
ctl019 out of specification map for all or dlbcl patients

Conditions: Acute Lymphoblastic Leukemia (ALL); Diffuse Large B-cell Lymphoma (DLBCL)

Summary: managed access program (map) to provide access to ctl019, for acute lymphoblastic leukemia (all) or diffuse large b-cell lymphoma (dlbcl) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

the purpose of this managed access program (map) treatment plan is to provide access to ctl019, for acute lymphoblastic leukemia (all) or diffuse large b-cell lymphoma (dlbcl) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product.

Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this treatment plan have to meet all of the following criteria: 1. patients must be treated at a healthcare facility that has been certified /qualified by novartis to dispense and administer tisagenlecleucel in line with the tisagenlecleucel risk evaluation and mitigation strategy (rems) in the united states (us) or the local risk management plan (rmp). - note that tisagenlecleucel treatment should be initiated under the direction of and supervised by a hcp experienced in the treatment of hematological malignancies and trained for administration and management of patients treated with tisagenlecleucel. the healthcare facility must have tocilizumab for use in the event of cytokine release syndrome and emergency equipment per patient prior to infusion on site and ensure timely access to additional doses of tocilizumab; for detailed requirements refer to the approved local label. 2. patients must be prescribed tisagenlecleucel in line with the locally approved indications (for the precise indication statements see approved local product label). these may include: * pediatric and young adult patients up to and (including) 25 years of age with refractory/relapsed (r/r) acute lymphoblastic leukemia (b-all) * adult patients with r/r diffuse large b-cell lymphoma (dlbcl) 3. informed consent must be obtained prior to treatment 4. the incoming apheresis material and/or the final manufactured product is out of specification due to failure to meet acceptance or release specifications exclusion criteria: patients eligible for this treatment plan must not meet any of the following criteria: 1. contraindications as per the approved local label or the ib.

Keywords: acute lymphoblastic leukemia all pediatric diffuse large b-cell lymphoma dlbcl adult relapse refractory ctl019 tisagenlecleucel kymriah cart19 cart car t cells chimeric antigen receptor manufacturing expanded access out of specification